RFP NUMBER 75N93026R00005- Final with Attachments.pdf

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: Public Law 81-692 as amended

2. Request for Proposal (RFP) Number: 75N93026R00005

3. Issue Date:

6/2/2026

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title: Radiological or Nuclear Medical Countermeasure Product Development Support (PDS)

6. ISSUED BY:

Office of Acquisition

National Institute of Allergy and Infectious Diseases

5601 Fishers Lane

Rockville, MD 20852

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

Any solicitation questions must be submitted on or before 7/02/2026

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 pm Eastern Time on 8/31/2026. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING

AND DELIVERY OF THE PROPOSAL."

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT

THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE

CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH [subparagraph (c)(3) of RFO Clause 52.215-1, Instructions to Offerors--Competitive Acquisition,"/HHSAR Clause 352.215-70, "Late Proposals and Revisions"] LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/ .

11. FOR INFORMATION CALL: Karen Telphia

PHONE: 240-669-2960

e-mail: karen.telphia@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

We strongly suggest that any questions regarding the solicitation be submitted by 3:00 PM EST, on July 2, 2026, so that we can provide timely responses before proposals are due.

Karen Telphia Contracting Officer Office of R&D and Professional Services Contracts Office of Acquisitions & Logistics Management https://www.sam.gov/SAM/

RFP TABLE OF CONTENTS

SOLICITATION

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. PRICES/COSTS

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

ARTICLE B.4. ADVANCE UNDERSTANDINGS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. DELIVERIES

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, RFO 52.252-2 (FEB 1998)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

ARTICLE G.3. TASK ORDER PROCEDURE

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, RFO

52.232-40 (Mar 2023)

ARTICLE G.6. INDIRECT COST RATES

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

ARTICLE G.8. GOVERNMENT PROPERTY

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. NOTICE TO OFFERORS – PROTECTION OF HUMAN SUBJECTS HHSAR 352.270-70 (MAR

2026) (RFO DEVIATION)

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

ARTICLE H.4. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN NIH-FUNDED

CLINICAL TRIALS

ARTICLE H.5. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION

ARTICLE H.6. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

ARTICLE H.7. CERTIFICATE OF CONFIDENTIALITY

ARTICLE H.8. SINGLE INSTITUTIONAL REVIEW BOARD (sIRB)

ARTICLE H.9. IDENTIFICATION OF SINGLE INSTITUTIONAL REVIEW BOARD (sIRB)

ARTICLE H.10. INCLUSION OF WOMEN AND MEMBERS OF RACIAL AND/OR ETHNIC MINORITY

GROUPS IN CLINICAL RESEARCH

ARTICLE H.11. INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN AS PARTICIPANTS IN RESEARCH

INVOLVING HUMAN SUBJECTS

ARTICLE H.12. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

ARTICLE H.13. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN

CLINICALTRIALS.GOV

ARTICLE H.14. REPORTING IN ELECTRONIC RESEARCH ADMINISTRATION (eRA) SYSTEM

ARTICLE H.15. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

ARTICLE H.16. PUBLIC HEALTH SURVEILLANCE EXCLUSION

ARTICLE H.17. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

ARTICLE H.18. 2024 NIH PUBLIC ACCESS POLICY

ARTICLE H.19. NEEDLE EXCHANGE, HHSAR 352.35-72 (Mar 2026)(RFO DEVIATION)

ARTICLE H.20. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.21. CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON FUNDING OF

HUMAN EMBRYO RESEARCH, HHSAR 352.235-73 (Mar 2026)(RFO DEVIATION)

ARTICLE H.22. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

ARTICLE H.23. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.235-75 (Mar 2026) (RFO

DEVIATION)

ARTICLE H.24. ANIMAL WELFARE

ARTICLE H.25. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

ARTICLE H.26. OMB CLEARANCE

ARTICLE H.27. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.28. GUN CONTROL

ARTICLE H.29. OPTION PROVISION

ARTICLE H.30. SUBCONTRACTING PROVISIONS

ARTICLE H.31. INFORMATION AND INFORMATION SYSTEMS SECURITY, HHSAR 352.204-71 (FEB

2024) (DEVIATION)

ARTICLE H.32. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE, HHSAR

352.239-78 (FEB 2024) (DEVIATION)

ARTICLE H.33. INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-

79 (FEB 2024) (DEVIATION)

ARTICLE H.35. STORAGE FACILITY REQUIREMENTS AND CERTIFICATION

ARTICLE H.36. CONFIDENTIAL INFORMATION, HHSAR 352.224-71 (FEB 2024) (DEVIATION)

ARTICLE H.37. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST

ARTICLE H. 38. PUBLICATION AND PUBLICITY

ARTICLE H.39. ADVANCED COPIES OF PRESS RELEASES

ARTICLE H.40. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

ARTICLE H.41. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.42. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

ARTICLE H.43. SHARING RESEARCH DATA

ARTICLE H.44. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.45. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

ARTICLE H.46. CONSTITUTION DAY

ARTICLE H.47. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

ARTICLE H.48. RECORDS MANAGEMENT, HHSAR 352.204-72 (FEB 2024) (DEVIATION)

ARTICLE H.49. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST

PART II - CONTRACT CLAUSES

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

SECTION M - EVALUATION FACTORS FOR AWARD

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide the facilities, expertise, and capabilities needed to develop additional radiological or nuclear medical countermeasures (MCMs) and support NIAID’s biodosimetry efforts.

One IDIQ contract will be awarded to an organization that can provide comprehensive product development services. NIAID will initiate, direct, and fund the work through Task Orders to support the research and development of radiological or nuclear MCMs and biodosimetry approaches along the drug or device development pathway to achieve approval, FDA licensure, or clearance. NIAID expects that the products for screening, testing, and development will come from industry, academia, and government agencies. Both the contractors and their collaborators are to have conducted some of the requested types of studies in accordance with Good Laboratory Practice (GLP) standards (21 CFR 58).

Their extensive range of capabilities should include:

• Developing animal models and New Approach Methodologies (NAMs)

• Conducting efficacy tests in rodent and large [nonhuman primates (NHPs] animal models for H- and

GI-ARS

• Assessing DEARE in rodent and large animal models (e.g., pigs and NHPs))

• Facilitating large animal sample distribution for testing candidate biodosimetry methods

• Evaluating radionuclide decorporation agents in rodent and canine models

• Performing animal safety studies, including pharmacokinetic and pharmacodynamic assessments

• Managing manufacturing and formulation processes

• Overseeing quality assurance activities

• Conducting Phase I Clinical Safety Studies

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by RFO 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ 2,500(minimum) nor more than a total of $ 135,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 7/01/2027 through 6/30/2034.

c. The Government will issue Task Orders based on the work described in SECTION C of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property;

12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

Invoice Processing Platform (IPP)

NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. The Contractor/Vendor shall use the attached NIH OFM Electronic Invoice Submission Instructions until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website at https://oalm.od.nih.gov/IPP. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date. Questions concerning the transition to IPP should be directed to NIH- IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

All IPP invoices must contain a Unique Entity Identifier (UEI) which is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

https://oalm.od.nih.gov/IPP mailto:NIH-IPPinvoicing@mail.nih.gov mailto:NIH-IPPinvoicing@mail.nih.gov

Protection of Proprietary Data

The Government anticipates that the Contractor will be utilizing and evaluating materials developed at private expense and subsequently provided to the Government by a third-party Supplier. It is essential to include provisions that will protect the proprietary rights of the Supplier.

All information provided by the Supplier or COR should be assumed to be confidential unless specifically identified as non-confidential in writing by the COR. Confidential information may not be revealed without written permission. All materials supplied to the Contractor and all test results similarly are to be considered confidential. All materials supplied to the Contractor shall be utilized solely for contract-related research purposes and no unauthorized use or distribution of these materials will be permitted.

Any data generated under this contract must be submitted for review by the COR before submission for public presentation or publication. Contract support shall be acknowledged in all such publications.

A 'publication' is defined as issue of printed material or a document produced electronically and offered for public distribution or any communication or oral presentation of information. The COR will review all submitted publications in a period of time not to exceed 90 calendar days from receipt, and will either agree to the publication/ disclosure, recommend changes or, as applicable, refer the document to the Supplier of the compound for their review. Information in any publication that is considered Confidential will be deleted by the COR and/or the Supplier prior to approval.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated December 12,2026 attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that one electronic version of the following reports will be required for any task orders:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of racial and/or ethnic minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the “NIH Policy and Guidelines on the Inclusion of Women and Members of Racial and/or Ethnic Minority Groups as Subjects in Clinical Research”, effective August 16, 2025 also applies. If this contract is for Phase III clinical trials, see Section B of these guidelines. The Guidelines may be found at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-131.html

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex , racial, and/or ethnic groups, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion https://grants.nih.gov/policy/inclusion/women-and-minorities.htm https://grants.nih.gov/policy/inclusion/women-and-minorities.htm of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex, racial and/or ethnic groups.

c. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in [Electronic/Hard Copy] format.

Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/default/files/web/508/contracting/technolog y/section_508_annual_report.doc.

3. REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT

DELIVERABLE SUBMISSION (eRDS) SITE

All reports required herein must be submitted in electronic format. All electronic contract deliverables must be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website:

https://erds.niaid.nih.gov/ . All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

https://www.ecfr.gov/current/title-45/part-94 https://www.ecfr.gov/current/title-45/part-94 https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://erds.niaid.nih.gov/ https://erds.niaid.nih.gov/ https://www.hhs.gov/web/section-508/index.html

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by [RFO Clause 52.227-11, Patent Rights-Ownership by the Contractor/RFO Clause 52.227-13, Patent Rights-Ownership by the Government] including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892- 7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see RFO 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before August 1, 2028. Thereafter, reports shall be due on or before the 30th Calendar day following the reporting period of the contract. The final invention statement (see RFO 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health

Office of Acquisition & Logistics Management, Office of R&D and Professional Service Contracts, Division A

6701 Rockledge Drive Bethesda, Maryland 20817

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov/

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Division of Allergy, Immunology, and Transplantation

5601 Fishers Lane

Rockville, MD 20852

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

RFO Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 7/1/2027 through 6/30/2034.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in RFO 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified in each Task Order.

b. The above items shall be addressed and delivered to:

All reports required herein shall be submitted in electronic format. All electronic contract deliverables shall be submitted via eRDS (NIAID's electronic Report Deliverable Submission), available at the following website: http://erds.niaid.nih.gov/. Attachment 29, eRDS Vendor Quick Reference is attached in Section J of the contract.

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, RFO 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

REVOLUTIONARY FAR OVERHAUL (RFO) (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

Alternate I (April 1984) is applicable to this contract.

http://erds.niaid.nih.gov/ https://www.acquisition.gov/?q=browsefar

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract: To be specified at the time of award

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause).

The following individual[(s)] [is/are] considered to be essential to the work being performed hereunder:

Name Title

To be specified at time of award

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order. If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs.

However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in RFO Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with RFO Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

▪ Understanding of the requirements;

▪ Experience and capability on similar tasks;

▪ Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies;

▪ Procedures for assuring quality of work, products, and deliverables;

▪ Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

▪ Staffing plan with skill levels and level of effort for each individual proposed.

Generally, resumes will be required for proposed personnel (if not previously submitted);

▪ References to evaluate past performance; and

▪ Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP. Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be more important than cost or price. However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

REPORT

a. Invoice Submission NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury’s Invoice Processing Platform

(IPP) at https://www.ipp.gov mailto:with a copy to the approving official for approval, as directed below and in accordance with the definitions of timeliness set forth in the invoice instructions included as an attachment in Section J of this Solicitation/Contract.

The contractor’s failure to submit timely invoice(s) to the Government waives the contractor’s rights to receive payment pursuant to this contract. In the event of this waiver, the Government is not obligated to make such payment, and the Contracting Officer shall have the authority to unilaterally deobligate the funds in accordance with the requirements at 31 U.S.C. 1552(a) and downwardly adjust the total amount of the award by the amount of the deobligation. The contractor shall be given an opportunity to request the excusal of a late invoice from the Contracting Officer. If excused, the Contracting Officer will respond in writing to confirm that the contactor’s right to receive payment has not been waived.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer

Name- TBD

Contracting Officer Representative

Name- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx .

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

2. In addition to the requirements specified in RFO 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is Office of Acquisition & Logistics Management, Research & Development and Professional Services, Division A.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

https://www.ipp.gov/ mailto:

mailto:ofm_customer_service@mail-cmp.niceincontact.com mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: Radiological or Nuclear Medical Countermeasure Product Development Support (PDS)

g. Contract Line Items as follows:

Line Item # Line Item Description

To be determined at time of award.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496- 6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

d. 'I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract.'

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, RFO

52.232-40 (Mar 2023).

(a) (1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause).

ARTICLE G.6. INDIRECT COST RATES

In accordance with Revolutionary FAR Overhaul (RFO) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the Cognizant Federal Agency Official (CFAO) responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services (DFAS) Office of Acquisition Management and Policy National Institutes of Health 6701 Rockledge Drive

4th Floor, MSC-7786 Bethesda, MD 20892-7786

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the DFAS Indirect Cost Branch's information package documents.

DFAS accepts only electronic submissions of indirect cost proposals. Go to the New Online Submission Guidance web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance for guidance on submitting indirect cost rate proposals electronically to DFAS.

Billing (Provisional) Rates:

In accordance with RFO 42.504, billing (provisional) rates must be established by the CFAO on the basis of information resulting from recent reviews, previous rate audits or experience, or similar reliable data or experience of other contracting activities.

The Contractor is required to submit a billing rate proposal to the CFAO identified above for the purpose of establishing and/or renewing expiring billing rates. As an administrative requirement, such submission shall be made no later than five (5) business days following the expiration of each of the Contractor's fiscal years.

https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance https://oamp.od.nih.gov/division-of-financial-advisory-services/new%20-online-submission-guidance

Failure to submit a timely billing rate proposal to the CFAO may result in establishment of billing rates unilaterally by the CFAO, based on audited historical data or other available data with unallowable costs excluded.

The contractor shall have an opportunity to request reasonable extensions in writing at least 30 days prior to the expiration of the active billing rate agreement. Requests may be granted in writing by the

CFAO.

The contractor shall notify the CFAO if/when the current billing (provisional) rates are no longer representative of current conditions and need to be renegotiated. This notification should include a revised indirect cost proposal and complete financial documentation to support a significant change in circumstances that warrants renegotiation of the rates.

The contractor shall utilize the IDC Submission Checklist found at: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for preparing the billing rate proposal.

Final Indirect Rates:

In accordance with RFO Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in PART II, SECTION I of this contract, the Contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer (or cognizant Federal agency official) and auditor within the 6-month period following the expiration of each of its fiscal years. Reasonable extensions, for exceptional circumstances only, may be requested in writing by the Contractor and granted in writing by the Contracting Officer.

FAR Clause 52.216-7 (d)(2) lists the full requirements for submission of an adequate final indirect cost rate proposal. In accordance with RFO 42.503-2(a), the Government must not accept a proposal or agree to establish final indirect cost rates unless the contractor certifies the costs are allowable. Failure to submit a certified final indirect rate proposal to the CFAO may result in establishment of final indirect rates unilaterally by the Government, based on audited historical data or other available data with unallowable costs excluded. These unilateral rates established by the Government shall be set low enough to ensure that unallowable costs will not be reimbursed (RFO 42.503-2(c)).

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with RFO Subpart 4211. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually to coincide with the anniversary date of the contract.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission

Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov .

End of clause.

ARTICLE G.8. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be found at:

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%2 0of%20Government%20Property-Appendix%20Q.pdf https://www.cpars.gov/ https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. NOTICE TO OFFERORS – PROTECTION OF HUMAN SUBJECTS HHSAR 352.270-70 (MAR

2026) (RFO DEVIATION)

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.

(1) These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information.

In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.104(d)(1)-(8) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, Offerors considered for award must file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects.